a study of (ly3650150) lebrikizumab to assess the safety and efficacy of adult and adolescent participants with moderate-to-severe atopic dermatitis and skin of color

Conditions: Atopic Dermatitis

Summary: the main purpose of this study is to determine the safety and efficacy lebrikizumab in adolescent and adult participants with moderate-to-severe atopic dermatitis (ad) and skin of color.


Eligibility criteria:
inclusion criteria: participants must be ≥12 years of age inclusive, at the time of signing the informed consent/assent. * participants who are self-reported race other than white, including but not limited to persons who self-identify as black or african american, american indian or alaska native, asian, native hawaiian, or other pacific islander. * participants who are fitzpatrick phototype iv-vi * participants who have chronic ad that has been present for ≥1 year before screening. * have easi ≥16 at baseline * have iga score ≥3 (scale of 0 to 4) at baseline * have ≥10% body surface area (bsa) of ad involvement at baseline * have a history of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable. * adolescents body weight must be ≥40 kg at baseline. * are willing and able to comply with all clinic visits and study-related procedures and questionnaires. * contraceptive use - male and/or female * male participants are not required to use any contraception except in compliance with specific local government study requirements. * female participants of child-bearing potential: must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 18 weeks after the last dose of study drug. women of non-child-bearing potential (non-wocbp) may participate without any contraception requirements. exclusion criteria: * history of human immunodeficiency virus (hiv) infection or positive hiv serology at screening. * have a current infection or chronic infection with hepatitis b virus (hbv) at screening, that is, positive for hepatitis b surface antigen (hbsag) and/or polymerase chain reaction positive for hbv dna * have a current infection with hepatitis c virus (hcv) at screening, that is, positive for hcv rna * have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening (as defined by the investigator). * have uncontrolled asthma that * might require bursts of oral or systemic corticosteroids, or * required the following due to ≥1 exacerbations within 12 months before baseline * systemic (oral and/or parenteral) corticosteroid treatment, or * hospitalization for \>24 hours. * have known liver cirrhosis and/or chronic hepatitis of any etiology. * had prior treatment with dupilumab * had prior treatment with tralokinumab * treatment with topical agents (corticosteroids, calcineurin inhibitors, jak inhibitors, or phosphodiesterase-4 inhibitors) within 2 weeks prior to baseline. * treatment with any of the following agents within 4 weeks prior to the baseline: * systemic immunosuppressive/immunomodulating drugs (for example, systemic corticosteroids, cyclosporine, mycophenolate mofetil, ifn-gamma, azathioprine, methotrexate, and other immunosuppressants); * small molecules (for example, janus kinase (jak) inhibitors); * phototherapy and photochemotherapy for ad. * history of malignancy, including mycosis fungoides or cutaneous t-cell lymphoma, within 5 years before the screening, except completely treated in situ carcinoma of the cervix of completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.

Keywords: eczema